Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP

Summary

The aim of this study is to support development of asciminib in the pediatric population (1 to \< 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.

Timeline

Start

2026-04-28

Primary completion

2033-02-23

Completion

2033-02-23

Drugs

Indications